MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN; INTRAVASCULAR CATHETER

Catalog Number 383590

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd nexiva¿ diffusics¿ closed iv catheter system 24 ga 0.75 in had air bubbles in the line.The following information was provided by the initial reporter: "it was reported that only a small amount of blood filled the tubing and did not back up to the end causing air in the line.Nurse states they use nexiva diffusics 383590 (lot#: 9232125).The nurse was inserting the device and once the vein was accessed only a small amount of blood filled the tubing.It did not back up all the way to the end and there was air in the line.Caller states the patient was very dehydrated.They went ahead and started the infusion and watched the patient and no adverse reactions were noted.".

Manufacturer Narrative

H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9232125.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h.10.

Event Description

It was reported that bd nexiva¿ diffusics¿ closed iv catheter system 24 ga 0.75 in had air bubbles in the line.The following information was provided by the initial reporter: "it was reported that only a small amount of blood filled the tubing and did not back up to the end causing air in the line.Nurse states they use nexiva diffusics 383590 (lot# 9232125).The nurse was inserting the device and once the vein was accessed only a small amount of blood filled the tubing.It did not back up all the way to the end and there was air in the line.Caller states the patient was very dehydrated.They went ahead and started the infusion and watched the patient and no adverse reactions were noted.".

• Brand Name: BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 24 GA 0.75 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9869492
• MDR Text Key: 206876967
• Report Number: 9610847-2020-00107
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: 00382903835904
• Combination Product (y/n): N
• PMA/PMN Number: K173354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 383590
• Device Lot Number: 9232125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 YR